Pneumonia-associated Acute Hypoxemic Respiratory FailureHFONCT03758508
Non-invasive Ventilation Versus High Flow Oxygen
A study testing High Flow Oxygen nasal cannula and Noninvasive ventilation in people with Pneumonia-associated Acute Hypoxemic Respiratory Failure, run by Niguarda Hospital at 1 site in Italy.
Trial summary
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia-associated Acute Hypoxemic Respiratory Failure
- What is being tested?
- High Flow Oxygen nasal cannula and Noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2017to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
- Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive for signs consistent with pneumonia
- Laboratory criteria: leukocytosis (White blood cells >10000/mcL) or leukopenia (White blood cells < 4000/mcL), rise of the inflammatory markers
- Radiologic criteria: consolidations at Chest X-ray or CT scan
- Hypoxemic respiratory failure, based on all the following criteria
- PaO2/FiO2 < 300 after at least 15 minutes conventional oxygen therapy with a FiO2 ≥ 50%
- Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles
- Informed consent to study participation
Who cannot join
- Age < 18 years
- Hypercapnic respiratory failure (pCO2 > 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease
- Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema
- Hemodynamic instability with necessity for use of inotropes and/or vasopressors
- Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) <8, agitation, device intolerance, respiratory arrest
- Immunosuppression (chronic immunosuppressive therapy, clinical history positive for any immunodeficiency - congenital or acquired)
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- Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication
- Tracheostomy
- Nocturnal CPAP ventilation therapy
- Any other condition which the clinician would considered an adjunctive risk for taking part in the study or that would not permit the participant to complete it
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Andrea Bellone, MD, 0039026444 ext. 7438, andrea.bellone@ospedaleniguarda.it
About this study
Official title: Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
Read the detailed description
Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated acute hypoxemic respiratory failure
- Being tested
- High Flow Oxygen nasal cannula, Noninvasive ventilation
- Keywords
- Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure
- Medical subject headings
- Pneumonia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Oxygen nasal cannulaDevice
High Flow Oxygen nasal cannula
Noninvasive ventilationDevice
In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| HFO | Active comparator | Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists Receives: Device: High Flow Oxygen nasal cannula |
| NIV/HFO | Active comparator | Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists Receives: Device: High Flow Oxygen nasal cannula; Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 improvement
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
Measured: at baseline and at 21 hours
Secondary outcomes (7)
Intensive Care admission
Rate of admission to Intensive Care Unit in the two arms
Measured: 30 days
Sensation of device comfort and dyspnoea
Evaluation of subjective sensation of device comfort and dyspnoea in the two arms
Measured: Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours
Time to downgrade to conventional oxygen therapy
Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula
Measured: 30 days
In-hospital mortality
Mortality rate in the 2 arms
Measured: 30 days
New hospital admission
Rate of a new hospital admission within 30 days
Measured: 30 days
PaO2/FiO2 improvement
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 45 hours compared to baseline PaO2/FiO2
Measured: at baseline and at 45 hours
PaO2/FiO2 improvement
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 30 hours compared to baseline PaO2/FiO2
Measured: at baseline and at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Nov 2017
- Primary completion1 Nov 2019
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia-associated Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758508
- Sponsor's protocol ID
- 03-022018
- Acronym
- HFO
- Status last verified
- Apr 2026
- First submitted
- 23 Nov 2018
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT03758508
- Acronym / sponsor ID
- HFO / 03-022018
- Keywords
- Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
Detailed description
Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated acute hypoxemic respiratory failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
| Arm | Type | Receives |
|---|---|---|
| HFO | Active comparator | Device: High Flow Oxygen nasal cannulaContinuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists |
| NIV/HFO | Active comparator | Device: High Flow Oxygen nasal cannula, Device: Noninvasive ventilationAlternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
- Hypoxemic respiratory failure, based on all the following criteria
- Informed consent to study participation
Key exclusion criteria (10 listed)
- Age < 18 years
- Hypercapnic respiratory failure (pCO2 > 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease
- Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema
- Hemodynamic instability with necessity for use of inotropes and/or vasopressors
- Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) <8, agitation, device intolerance, respiratory arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Oxygen nasal cannulaHigh Flow Oxygen nasal cannula | Device | HFO, NIV/HFO |
| Noninvasive ventilationIn this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula | Device | NIV/HFO |
Primary outcome
PaO2/FiO2 improvement
Time frame: at baseline and at 21 hours
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
7 secondary outcomes
Intensive Care admission
Time frame: 30 days
Sensation of device comfort and dyspnoea
Time frame: Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours
Time to downgrade to conventional oxygen therapy
Time frame: 30 days
In-hospital mortality
Time frame: 30 days
New hospital admission
Time frame: 30 days
PaO2/FiO2 improvement
Time frame: at baseline and at 45 hours
PaO2/FiO2 improvement
Time frame: at baseline and at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Oxygen nasal cannula and Noninvasive ventilation in people with Pneumonia-associated Acute Hypoxemic Respiratory Failure, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Bellone, MD (00396444 ext. 2495, andrea.bellone@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 improvement (time frame: at baseline and at 21 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.